Lyme disease (LD) Infections and Infestations Lyme disease
Conditions
Interventions
Ketek® versus Amoxicillin (comparator)
Sponsors
First Medical Associates (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinically suspected recurrent LD evaluated in a primary care setting in a Lyme disease endemic area, will be eligible for participation in the study if they meet the selection criteria: 1. Clinically documented disease described by Asch et al. and Logigian et al. 2. History of previous oral and intravenous antibiotics 3. Age 18 years or older to include the elderly (no upper age limits will be established) 4. Both sexes 5. A written informed consent document regarding the experimental nature of the study 6. Ability to comply with the protocol follow-up 7. Women of childbearing potential must be using a medically acceptable method of birth control and have a negative serum Human Chorionic Gonadotropin (HCG) pregnancy test result at the initial screening visit
Exclusion criteria
Exclusion criteria: Exclusion criteria will be limited to secure inclusion of as many patients as possible, thus avoiding difficulties in generalising the results. Patients will be excluded from the study if: 1. They have not previously been treated for at least 21 days with an antibiotic known to be effective for Lyme disease 2. They are not able to return for follow-up 3. They have a history of allergies to erythromycin, macrolides, or Ketek® 4. They have a history of allergies to both amoxicillin and doxycycline 5. They are pregnant or are a postpartum/lactating female who is nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success using clinical impression | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short Form health survey (SF-36) 2. Review Of Symptoms Scale (ROSS) | — |
Countries
United States of America
Outcome results
None listed